Method, Development and Validation of Emtricitabine and Tenofovir by Using RP-HPLC in Pharmaceutical Dosage Forms

Abstract

A new method was established for simultaneous estimation of Emtricitabine and Tenofovir by RP-HPLC method. The chromatographic conditions were successfully developed for these parathions of Emtricitabine and Tenofovir by using Xterra C185 µm (4.6*250 mm) column, flowrate was1ml/min, mobile phase ratio was phosphate buffer (0.05 M) pH4.6: CAN (55:45% v/v) (pH was adjusted with ortho-phosphoric acid), detection wavelength was 255nm. Theretentiontimewas2.399and3.907 min. for Emtricitabine and Tenofovir, respectively. The percentage purity of EmtricitabineandTenofovirwasfoundtobe100.7%and 101.4%respectively. The analytical method was validated according to ICH guidelines (ICH, Q2(R1)). The linearity ranges were observed at 1–5μg for Emtricitabineand100–500μg for Tenofovir. The precision study was precise, robust, and repeatable. LODvaluewas2.95and3.04, and LOQ value was 9.87and10 respectively. The present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible spectroscopic method for the simultaneous analysis of Emtricitabine and Tenofovir in API and pharmaceutical dosage form. Keywords: Emtricitabine, Tenofovir, RP -H P L C, buffer Cite this Article V. Rajashakar, S. K. Godasu, M. Chinna Eswaraiah. Method, Development and Validation of Emtricitabine and Tenofovir by Using RP-HPLC in Pharmaceutical Dosage Forms. Research & Reviews: A Journal of Drug Formulation, Development and Production . 2018; 5(1): 37–41p.